Bill Text: TX HB810 | 2017-2018 | 85th Legislature | Introduced

NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Relating to the provision of certain investigational stem cell treatments to patients with certain severe chronic diseases or terminal illnesses and regulating the possession, use, and transfer of adult stem cells; creating a criminal offense.

Spectrum: Moderate Partisan Bill (Republican 18-5)

Status: (Passed) 2017-06-12 - Effective on 9/1/17 [HB810 Detail]

Download: Texas-2017-HB810-Introduced.html
  85R4702 SCL-F
 
  By: Parker H.B. No. 810
 
 
 
A BILL TO BE ENTITLED
 
AN ACT
  relating to the provision of certain investigational stem cell
  treatments to patients with certain severe chronic diseases or
  terminal illnesses.
         BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
         SECTION 1.  Chapter 1003, Health and Safety Code, is amended
  by designating Sections 1003.001, 1003.002, and 1003.003 as
  Subchapter A and adding a subchapter heading to read as follows:
  SUBCHAPTER A. GENERAL PROVISIONS
         SECTION 2.  Chapter 1003, Health and Safety Code, is amended
  by adding Subchapter B to read as follows:
  SUBCHAPTER B. PROVISION OF INVESTIGATIONAL STEM CELL TREATMENTS TO
  PATIENTS WITH CERTAIN SEVERE CHRONIC DISEASES OR TERMINAL ILLNESSES
         Sec. 1003.051.  DEFINITIONS. In this subchapter:
               (1)  "Investigational stem cell treatment" means an
  adult stem cell treatment that:
                     (A)  is under investigation in a clinical trial
  and being administered to human participants in that trial; and
                     (B)  has not yet been approved for general use by
  the United States Food and Drug Administration.
               (2)  "Severe chronic disease" means a condition,
  injury, or illness that:
                     (A)  may be treated;
                     (B)  is never cured or eliminated; and
                     (C)  entails significant functional impairment or
  severe pain.
               (3)  "Terminal illness" means an advanced stage of a
  disease with an unfavorable prognosis that, without
  life-sustaining procedures, will soon result in death or a state of
  permanent unconsciousness from which recovery is unlikely.
         Sec. 1003.052.  RULES. The executive commissioner shall
  adopt rules designating the medical conditions that constitute a
  severe chronic disease or terminal illness for purposes of this
  subchapter.
         Sec. 1003.053.  PATIENT ELIGIBILITY. A patient is eligible
  to access and use an investigational stem cell treatment under this
  subchapter if:
               (1)  the patient has a severe chronic disease or
  terminal illness listed in the rules adopted under Section 1003.052
  and attested to by the patient's treating physician; and
               (2)  the patient's physician:
                     (A)  in consultation with the patient, has
  considered all other treatment options currently approved by the
  United States Food and Drug Administration and determined that
  those treatment options are unavailable or unlikely to alleviate
  the significant impairment or severe pain associated with the
  severe chronic disease or terminal illness; and
                     (B)  has recommended or prescribed in writing that
  the patient use a specific class of investigational stem cell
  treatment.
         Sec. 1003.054.  INFORMED CONSENT. (a)  Before receiving an
  investigational stem cell treatment, an eligible patient must sign
  a written informed consent.
         (b)  If the patient is a minor or lacks the mental capacity to
  provide informed consent, a parent, guardian, or conservator may
  provide informed consent on the patient's behalf.
         (c)  The executive commissioner by rule may adopt a form for
  the informed consent under this section.
         Sec. 1003.055.  NO CAUSE OF ACTION CREATED. This subchapter
  does not create a private or state cause of action against a
  developer of an investigational stem cell treatment or against any
  other person or entity involved in the care of an eligible patient
  using the investigational stem cell treatment for any harm done to
  the eligible patient resulting from the investigational stem cell
  treatment.
         Sec. 1003.056.  EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL
  TRIAL ENROLLEES. This subchapter does not affect the coverage of
  enrollees in clinical trials under Chapter 1379, Insurance Code.
         Sec. 1003.057.  ACTION AGAINST PHYSICIAN'S LICENSE
  PROHIBITED. Notwithstanding any other law, the Texas Medical Board
  may not revoke, fail to renew, suspend, or take any action against
  a physician's license under Subchapter B, Chapter 164, Occupations
  Code, based solely on the physician's recommendations to an
  eligible patient regarding access to or use of an investigational
  stem cell treatment, provided that the care provided or
  recommendations made to the patient meet the standard of care and
  the requirements of this subchapter.
         Sec. 1003.058.  GOVERNMENTAL INTERFERENCE PROHIBITED. (a)
  In this section, "governmental entity" means this state or an
  agency or political subdivision of this state.
         (b)  A governmental entity or an officer, employee, or agent
  of a governmental entity may not interfere with an eligible
  patient's access to or use of a stem cell treatment authorized under
  this subchapter.
         SECTION 3.  As soon as practicable after the effective date
  of this Act, the executive commissioner of the Health and Human
  Services Commission shall adopt rules necessary to implement
  Subchapter B, Chapter 1003, Health and Safety Code, as added by this
  Act.
         SECTION 4.  This Act takes effect immediately if it receives
  a vote of two-thirds of all the members elected to each house, as
  provided by Section 39, Article III, Texas Constitution.  If this
  Act does not receive the vote necessary for immediate effect, this
  Act takes effect September 1, 2017.
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